Ra Coordinator - Hyderabad, Telangana, India - Novartis
Description
390691BRRA Coordinator:
India
About the role
Your responsibilities include, but are not limited to:
- Independently manage and prepare routine Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment, and New Investigator Submissions to ensure timely submissions in accordance with the FDA regulations
- Contribute to Module #1 documents including FDA forms and cover letters for maintenance/nonmaintenance submissions with management oversight
- Conduct monthly reconciliation to ensure timely submissions are in accordance with FDA regulations as well as meeting all Novartis requirements for submissionrelated activities
- Proactively identify issues, gaps, and tradeoffs affecting optimal and timely submission. Independently manage US regulatory compliance activities, including timely review and updates to product specific information as provided by program team representative into a compliance database (DRAGON), when applicable
- Independently manage the user fee registration requests. Independently manage and execute drug shipment ticket review process (US)
- In addition to regulatory manager, provide guidance to clinical functions on regulatory compliance activities, such as requirements for TOOs, VDRs, drug shipment etc.
- Assist regulatory managers to support compilation and release of submissions to regulatory agencies as well as submissionrelated activities for regulatory responses to health authorities
- Where appropriate, participating in kickoff meetings for NDA/IND annual reports and QC of NDA annual reports from previous versions (US). Where appropriate, perform QC of approved label versus previous versions with adequate management oversight
Commitment to Diversity & Inclusion:
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
Role Requirements
- Minimum of 3 years pharmaceutical experience with a minimum of 12 years of regulatory experience preferred.
- Prior publishing/Regulatory Operations experience desired.
- Good communication and negotiation skills.
- Proactive personality.
- Fast and flexible, focused on timely delivery and stretch targets
- Ability to plan and prioritize workload
- Ability to work in a matrixed environment.
- Ability to build effective relationships across teams/projects.
WHY NOVARTIS
769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility.
And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges.
Because the greatest risk in life, is the risk of never trying Imagine what you could do here at NovartisCommitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
Division
Development
Business Unit
REG AFFAIRS GDD
Work Location
Hyderabad, AP
Company/Legal Entity
Nov Hltcr Shared Services Ind
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
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